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November 14, 2023

USDA, EPA, and FDA Post Report on Stakeholder Comments on Coordinated Framework for the Regulation of Biotechnology and Plain-Language Regulatory Information

Lynn L. Bergeson Carla N. Hutton

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation:

As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) issued a request for information (RFI) on behalf of the primary agencies that regulate the products of biotechnology — USDA, EPA, and FDA — requesting relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900.

According to the Report on Stakeholder Outreach, in reviewing the comments on the RFI, several themes emerged: (1) requests for greater regulatory clarity; (2) requests for greater regulatory coordination and harmonization; (3) requests for regulatory reform or revision; and (4) comments on regulatory resources. The Report on Stakeholder Outreach summarizes comments representing each area.

As reported in our January 9, 2017, memorandum, the Coordinated Framework for the Regulation of Biotechnology outlines a comprehensive U.S. regulatory policy for ensuring the safety of biotechnology products and was most recently updated in 2017. To help developers and the public better understand U.S. regulatory processes for biotechnology products, the Plain Language Document provides a high-level overview of the roles and responsibilities of U.S. regulatory agencies under the Coordinated Framework. Because the United States uses existing laws to regulate products of biotechnology, different agencies may regulate different aspects and uses of a product. As represented in Table 1, multiple offices, programs, and centers within USDA, EPA, and FDA are involved in biotechnology regulation. The Plain Language Document suggests that new entrants to the regulatory system and members of the public can use Table 2 to determine which agency or agencies may regulate particular product types. The Plain Language Document includes examples of case studies describing how specific product types would be regulated by each agency for plants, plant cells, and plant products of biotechnology in Table 3; for animals, animal cells, and animal products produced with biotechnology in Table 4; and for microorganisms produced with biotechnology, microbial cells, and microbial products produced with biotechnology in Table 5. The Plain Language Document notes that these case study examples are not intended to be inclusive of all products of biotechnology.